The Positively Quit Trial: Addressing Disproportionate Smoking Rates Among People Living With HIV

Note: Public-facing information will not reveal that the study is specifically for people living with HIV; instead these documents refer to "people living with certain health conditions. This trial involves a highly stigmatized, vulnerable, and private group: people living with HIV. The team does not wish to make it known publicly that this trial is for people living with HIV, as that could lead to other people inadvertently learning someone's HIV-positive status, which would be a major privacy violation. For example, if a participant receives email or text from the Positively Quit Study, there is no easy way for another person to know the study is only for those living with HIV. However, if the website notes the inclusion requirement of living with HIV on clinicaltrials.gov, a boyfriend, roommate, family member, etc., could look up the Positively Quit Trial on clinicaltrials.gov and then determine that their boyfriend, roommate, family member, etc. is HIV-positive. Eligibility criteria are deliberately incomplete to protect the privacy of people living with HIV. Moreover, some details are left out of the eligibility criteria to prevent participants from qualifying for the study because they knew the "correct" answers to the eligibility screens--not because they actually met criteria.

After completing eligibility screening, including a video-conferencing observed swab test to measure levels of cotinine (a marker of cigarette smoking chemicals), those eligible will be invited to complete the baseline assessment and enroll in the trial.

Enrolled participants will then complete a baseline assessment (the first assessment for the trial, consisting of a secure online survey). Then they will be randomized to either the treatment condition or the AMC. Randomization is a fair way of selecting who will be in each condition. It is like flipping a coin. In this study, instead of actually flipping a coin, the team will use a web-based randomization software that basically does the same thing. Once a participant learns their randomized condition, they will receive brief cessation counseling and an offer of nicotine replacement therapy (NRT) patches. For participants who would like NRT, study staff will help determine if the participant can get NRT through their insurance or related assistance program (e.g., ADAP); if it is possible, the study staff will facilitate that process. If getting NRT through insurance, etc. is not possible, NRT will be provided by the study.

Participants will begin their group sessions within approximately 2 weeks of randomization. For both conditions, the group sessions will all be conducted using group-based video-conferencing via Zoom, a HIPAA compliant video-conferencing system that is easy to use, works well even at lower internet speeds, and is free to trial participants; this will be the same system participants used during eligibility screening. Participants will be required to join the group from a private space, with no others present, to ensure confidentiality for all participants. Those who violate this requirement will be asked to resolve the situation immediately or log out of the session. A second violation will lead to permanent removal from the group sessions, because confidentiality is critical. Groups for both conditions will consist of 8 sessions over 6 weeks, with subsequent booster sessions 2,4,8, and 12 weeks after the end of the main interventions.

For each condition, one facilitator will be a master's level counselor and one will be a peer (person living with certain health condition). Facilitators will be trained for only one group type (there will be 1-2 sets of facilitators for treatment and a separate 1-2 sets of facilitators for AMC). All facilitators will undergo supervision with the PI and Co-I.